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January 07, 2013

Supreme Court Denies Certiorari in Stem Cell Funding Case

In an order
issued earlier today, the Supreme Court denied certiorari in Sherley v.
Sebelius, ending the efforts by two adult stem cell researchers to prevent the National Institutes of
Health (NIH) from funding research using human embryonic stem cells (ESCs). The dispute arose following
the NIH's release in July 2009 of new guidelines governing the requirements for
federal funding of research on human ESCs (see "NIH Releases New Stem Cell
Rules"). The NIH's guidelines replaced rules promulgated
during the Bush Administration that limited the number of funding-eligible human
stem cell lines to 69. Under the NIH's new
guidelines, which were developed in response to an Executive Order issued by
President Obama in March 2009 (see "President Obama to Lift Stem Cell
Limits on Monday"),
human ESCs that are listed on the NIH's stem cell registry (established pursuant to
the guidelines) are eligible for funding.
The guidelines permitted human ESCs that were created using in vitro fertilization for reproductive
purposes, but which we no longer needed for this purpose, to be listed on the
registry.

In response to the NIH's
promulgation of the stem cell guidelines, Dr. James Sherley and Dr. Theresa
Deisher, two researchers who only use adult stem cells in their research, filed
suit, along with several other plaintiffs, to enjoin the NIH from funding
research using human ESCs. In
particular, the Appellees contended that by funding research projects using
ESCs, the NIH violated the Dickey-Wicker Amendment, which Congress has included
in the annual appropriation for the Department of Health and Human Services
each year since 1996. The Dickey-Wicker Amendment
prohibits the NIH from funding:

(1) the creation of a human embryo or embryos
for research purposes; or (2) research in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death greater than that
allowed for research on fetuses in utero under 45 C.F.R. 46.204(b) and section
498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

The District Court for the
District of Columbia granted the Government's motion to dismiss the suit for lack
of standing, the plaintiffs appealed, and the U.S. Court of Appeals for the
District of Columbia Circuit remanded, finding that Drs. Sherley and Deisher
had standing because they competed with human ESC researchers for NIH
funding. On remand, the District Court granted
Appellees' motion for a preliminary injunction, concluding that they were
likely to succeed in showing that the NIH's guidelines violated the
Dickey-Wicker Amendment. On appeal, the
U.S. Court of Appeals for the District of Columbia Circuit vacated the
preliminary injunction, finding that the Appellees were unlikely to prevail
because the Dickey-Wicker Amendment is ambiguous and the NIH reasonably
concluded that, although the Dickey-Wicker Amendment bars funding for the
destructive act of deriving a human ESC from an embryo, it does not prohibit
funding a research project in which a human ESC will be used.